ArticleBiochemia medica2018
Using Sigma metrics to establish analytical product performance requirements and optimize analytical performance of an
Article in Biochemia medica, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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3 citing papers in PubMed, 7 citations in OpenAlex.
- Utility of process capability indices in assessment of quality control processes at a clinical laboratory chain.Journal of clinical laboratory analysis · 2021Article
- Comparative analysis of calculating sigma metrics by a trueness verification proficiency testing-based approach and an internal quality control data inter-laboratory comparison-based approach.Journal of clinical laboratory analysis · 2019Article
- Special issue on Six Sigma metrics - experiences and recommendations.Biochemia medica · 2018Article
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEstablishing analytical performance requirements for in vitro diagnostic (IVD) assays is a challenging process. Manufacturers try to optimize analytical performance by choosing amongst many combinations of different product performance characteristics. Sigma metrics and method decision charts can be helpful aids in choosing appropriate analytical performance requirements. The objective of this research was to demonstrate the use of Sigma metrics and method decision charts to help establish analytical performance requirements and to optimize analytical performance at medical decision concentrations for an IVD assay. MATERIALS AND
methodsA range of possible Sigma metrics were determined using three sources for total allowable error (TEa) and hypothetical total PSA assay results. Method decision charts were created for each TEa source and used to identify the maximum precision and bias that the assay could have to maintain sigma level performance of at least 3.
resultsTo achieve a sigma performance level of at least 3 for a hypothetical total PSA assay, the maximum allowable coefficient of variation ranged from 5.0% to 11.2% depending on the TEa source. To achieve a sigma performance level of at least 6, the maximum allowable coefficient of variation ranged from 2.5% to 5.6% depending on the TEa source.
conclusionsUsing Sigma metrics and method decision charts when establishing analytical performance requirements can help manufacturers choose product requirements that will optimize IVD assay product performance.
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